Caption Guidance

K200755

Caption Health · cleared 2020-04-16 · product code QJU · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers.”
AlgorithmArtificial intelligence to emulate the expertise of sonographers, including Quality Meter, Prescriptive Guidance, Auto-Capture, and Save Best Clip features.
source quote (p.4)
“Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers. ... Quality Meter: The real-time feedback from the Quality Meter advises the user on the expected diagnostic quality of the resulting clip, such that the user can make decisions to further optimize the quality, for example by following the prescriptive guidance feature below. Prescriptive Guidance: The prescriptive guidance feature in Caption Guidance provides direction to the user to emulate how a sonographer would manipulate the transducer to acquire the optimal view. Auto-Capture: The Caption Guidance Auto-Capture feature triggers an automatic capture of a clip when the quality is predicted to be diagnostic, emulating the way in which a sonographer knows when an image is of sufficient quality to be diagnostic and records it. Save Best Clip: This feature continually assesses clip quality while the user is scanning and, in the event that the user is not able to obtain a clip sufficient for Auto-Capture, the software allows the user to retrospectively record the highest quality clip obtained so far, mimicking the choice a sonographer might make when recording an exam.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.6)
“The software documentation included: ... 11. Cybersecurity”

Validation studies (2)

Bench

sample size not stated

endpoints: Frame-level PG prediction of the probe maneuver needed to acquire an image/frame of heart, for a specific view.; Clip-level PG prediction of the probe maneuver needed to acquire a diagnostic quality clip for a specific view.

Reader study (MRMC)

n=16 patients

endpoints: assess the critical tasks potentially impacted by the modification to the prescriptive guidance features; no use errors associated with critical tasks likely to lead to patient injury

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K201992 (decision 2020-09-18) from Caption Health for a matching device line ("Caption Guidance") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K201992

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K200755